SIEMENS SONOCUR BASIC SYSTEM
FDA premarket approval P010039 · decided 2002-07-19
Approval details
- PMA number
- P010039
- Trade name
- SIEMENS SONOCUR BASIC SYSTEM
- Generic name
- Generator, shock-wave, for pain relief
- Applicant
- Siemens Medical Solutions USA, Inc.
- Date received
- 2001-07-27
- Decision date
- 2002-07-19
- Days to decision
- 357 days
- Decision code
- APWD
- Product code
- NBN
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Mavern, PA
- Statement
- APPROVAL FOR THE SIEMENS SONOCUR BASIC. THE SIEMENS SONOCUR BASIC IS A NON-SURGICAL ALTERNATIVE FOR THE TREATMENT OF CHRONIC LATERAL EPICONDYLITIS (COMMONLY REFERRED TO AS TENNIS ELBOW) FOR PATIENTS WITH SYMPTOMS OF CHRONIC LATERAL EPICONDYLITIS FOR 6 MONTHS OR MORE AND A HISTORY OF UNSUCCESSFUL CONSERVATIVE TREATMENTS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| syngo.CT Coronary Cockpit (K253786) | Siemens Medical Solutions USA, Inc. | 2026-06-25 |
| MAMMOMAT B.brilliant (11372950) (K253678) | Siemens Medical Solutions USA, Inc. | 2026-06-18 |
| ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System (K260844) | Siemens Medical Solutions USA, Inc. | 2026-06-16 |
| Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family (K261315) | Siemens Medical Solutions USA, Inc. | 2026-05-21 |
| syngo Application Software (K254184) | Siemens Medical Solutions USA, Inc. | 2026-04-29 |
| ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno (K254173) | Siemens Medical Solutions USA, Inc. | 2026-04-24 |
| ARTIS genio floor; ARTIS icono.explore floor (K253752) | Siemens Medical Solutions USA, Inc. | 2026-04-23 |
| SOMATOM X.cite; SOMATOM X.ceed (K253574) | Siemens Medical Solutions USA, Inc. | 2026-03-20 |